Sympathomimetic Agent

Ephedrine for Childbirth

Icahn School of Medicine at Mount SInai, New York, NY
Ephedrine +1 morePhase 4RecruitingResearch Sponsored by Icahn School of Medicine at Mount Sinai

Study Summary

This trial will study if ephedrine given before epidural anesthesia placement can reduce the number of Category II fetal heart rate tracings and low blood pressure due to labor analgesia.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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Before receiving certain types of anesthesia, the baby's heart rate should be checked and should be normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ day 1, 30 minutes after administration of intrathecal opiate
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 30 minutes after administration of intrathecal opiate for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of category II fetal heart rate tracing
Secondary outcome measures
Average HR changes
Average blood pressure changes
Incidence of antihypertensive treatment after ephedrine administration
+7 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EphedrineExperimental Treatment1 Intervention
3 minutes after the placement of a combined spinal epidural with 25 mcg fentanyl, 7.5 mg ephedrine IV will be administered to the patient, 12 minutes later, a second dose of 7.5mg will be administered to the patient as long as the patient is not hypertensive (BP no greater than 140/90)
Group II: PlaceboPlacebo Group1 Intervention
3 minutes after the placement of a combined spinal epidural with 25 mcg fentanyl, 2.5cc 0.9% NS IV will be administered to the patient, 12 minutes later, a second dose of , 2.5cc 0.9% NS will be administered to the patient.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ephedrine
2016
Completed Phase 4
~26810

Find a site

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
816 Previous Clinical Trials
510,739 Total Patients Enrolled
James LeaderStudy Director
Icahn School of Medicine at Mount Sinai

Media Library

Ephedrine (Sympathomimetic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05873218 — Phase 4
Childbirth Research Study Groups: Ephedrine, Placebo
Childbirth Clinical Trial 2023: Ephedrine Highlights & Side Effects. Trial Name: NCT05873218 — Phase 4
Ephedrine (Sympathomimetic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05873218 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment accept applicants over the age of eighty?

"This medical study is open to individuals aged 18-55."

Answered by AI

Is there an opportunity to participate in this medical research?

"To be eligible, candidates of child-bearing age (18 to 55) are encouraged to apply. The research team aims to enrol 150 participants in total."

Answered by AI

Are there any adverse effects associated with Ephedrine use?

"Given the fact that this is a Phase 4 clinical trial, our team at Power has rated ephedrine's safety as 3. This signifies that it has been sanctioned for use by medical professionals."

Answered by AI

Are there still available slots for participants in this medical experiment?

"According to information obtained from clinicaltrials.gov, this medical trial is not actively accepting applications at present. Inaugurated on May 1st 2023 and last updated 23 days later, the trail has ceased recruiting patients for now; yet four other studies are still in search of volunteers."

Answered by AI
~100 spots leftby Apr 2025